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Senior Scientist II / Principal Scientist I, Biologics Drug Product Development

AbbVie•North Chicago, IL
•Onsite
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About The Position

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’s R&D, is a global organization that is responsible for drug product formulation and process development, and definition of the product presentation for biologics (proteins, conjugates, peptides, neurotoxins etc.) and genetic medicine (AAV, LNPs, Cell Therapy). AbbVie is seeking a highly motivated candidate for the position of Senior Scientist II / Principal Scientist I, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics drug product formulation and process development, scale-up and tech transfer. This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery research, analytical research and development, bioprocess development, combination products development, product development science and technology, pilot plants and third-party manufacturers.

Requirements

  • BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines
  • Senior Scientist II: 12+ (Bachelors), 10+ (Masters), or 4+ (PhD) years of relevant industry experience.
  • Principal Scientist I: 14+ (Bachelors), 12+ (Masters), or 6+ (PhD) years of relevant industry experience.
  • Proven ability to solve critical scientific problems.
  • Experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product process development.
  • Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization), characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring.
  • Experience leading drug product development as the functional lead within cross-functional teams

Nice To Haves

  • Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products
  • Understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products
  • Experience in managing third party manufacturers of sterile parenteral products
  • Experience with quality risk management and control strategies for biologics and sterile parenteral products

Responsibilities

  • Represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
  • Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
  • Support scale-up and technology transfer activities to internal and external manufacturing sites.
  • Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
  • Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.

Benefits

  • paid time off (vacation, holidays, sick)
  • medical/dental/vision insurance
  • 401(k)
  • short-term incentive programs

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What This Job Offers

Job Type

Full-time

Career Level

Senior

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Based on current job postings on Teal, the average Senior Scientist salary in the US is approximately $139,000 per year, with a typical range of $84,000 to $199,000.

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